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GLYPALCARE STUDY - Multicenter, Randomized Study for Evaluating Continuous Glucose Monitoring (CGM) by Using FreeStyle Libre 2 (FSL2) for Preventing Hyperglycemia/Hypoglycemia Crisis in Advanced Oncological Patients.

Primary Purpose

Palliative Care, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Continuous Glucose Monitoring
Standard Care
Sponsored by
Antea Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Palliative Care focused on measuring Palliative care, Diabetes, Cancer, Advanced cancer, End Stage Cancer, Terminal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged > or = 18 years
  • Diagnosed with advanced oncological disease
  • Known/newly diagnosed DM according to ADA criteria
  • Need of a Insulin therapy and need of Glycemia Monitoring with at least three finger pricks/die
  • Karnofsky Index >= 30
  • Provision of signed and dated informed consent form

Exclusion criteria:

  • Diagnosis of all types of Dementia
  • Presence of severe psychiatric diseases/symptoms
  • Kidney failure requiring dialysis
  • Patients with implanted pacemaker

Sites / Locations

  • Palliative care Service - Sheba Medical Centre
  • Antea Foundation
  • Centro di Cure Palliative "Insieme nella Cura" - Policlinico Universitario - Campus Bio-Medico (Roma)
  • Unità Operativa Complessa di Oncologia Medica - Policlinico Univeristario Campus Bio-medico di Roma
  • Fondazione FARO
  • Hospiz im Park

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Continuous Glucose Monitoring

Standard Care

Arm Description

The FreeStyle Libre 2 Flash Glucose Monitoring System (FSL2) is a CGM device with real time alarms capability indicated for the management of diabetes in persons aged 4 and older. The Sensor holds eight (8) hours of data at a time. In order to have a daily diary of the Glucose level the patients or family or HCP must read the sensor (with reader or app) at least every height (8) hours. Every day at least three (3) scans of the sensor should be performed using the reader or the Smartphone App, generally at wake up in the morning, in the afternoon and at the time to go to sleep. The alarm system will be activated, so that the Glucose level is over the cut off limit of 180 mmol/L or when it is lower than the cut-off limit of 80 mmol/L, the patient and/or the family members and/or the caregiver will check the Glucose level by scanning the reader/smartphone over the sensor.

This arm will perform the usual standard routine for blood glucose monitoring in patients with insulin therapy, that is represented by at least three finger pricks/die according to the usual standards routine of each center. Different frequency of finger pricks glucose measurements could be performed on the basis of health care professional patient assessment of each patient's needs.

Outcomes

Primary Outcome Measures

Evaluate CGM by using FSL2 in preventing severe hyperglycemia peaks
First severe hyperglycemic peak (>250 mg/dL) observed during evaluation

Secondary Outcome Measures

Full Information

First Posted
June 18, 2021
Last Updated
July 20, 2021
Sponsor
Antea Foundation
Collaborators
Abbott Diabetes Care
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1. Study Identification

Unique Protocol Identification Number
NCT04942756
Brief Title
GLYPALCARE STUDY - Multicenter, Randomized Study for Evaluating Continuous Glucose Monitoring (CGM) by Using FreeStyle Libre 2 (FSL2) for Preventing Hyperglycemia/Hypoglycemia Crisis in Advanced Oncological Patients.
Official Title
GLYPALCARE STUDY - Multicenter, Randomized Study for Evaluating Continuous Glucose Monitoring (CGM) by Using FreeStyle Libre 2 (FSL2) for Preventing Hyperglycemia/Hypoglycemia Crisis in Advanced Oncological Patients With Known/Newly Diagnosed Type I/Type II Diabetes Mellitus (DM) in Palliative Care/ Supportive Care (PC/SC) Setting.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antea Foundation
Collaborators
Abbott Diabetes Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cancer patients with known or newly diagnosed (i.e. iatrogenic) Diabetes Mellitus (DM) in Palliative/Supportive Care will be enrolled. Patients will be randomly assigned to one of two groups. Patients included in the first group will monitor glucose levels through Continuous Glucose Monitoring (CGM), using the FreeStyle Libre 2 (FSL2). The second group is represented by the usual standard way for blood glucose (BG) monitoring (lancing device for finger samples). An interim analysis is foreseen when the half of the expected events (hyperglycemic peaks) will be observed. In case the results of interim analysis show superiority of the CGM (FSL2) group patients of the second group will be switched.
Detailed Description
Diabete Mellitus (DM) represents an emerging factor with an impact on the severity and the management of symptoms (pain, dyspnoea, fatigue, nausea, vomiting, dehydration) in PC/SC patients leading to a reduced QoL of patients and family members. It has been noted that infrequent Blood Glucose (BG) monitoring might result in a not clear definition about whether symptoms are associated with the dying process or caused by diabetes, leading to inadequate symptoms management. It is estimated that more than 30% of PC/SC patients can be affected by DM type I or type II. The incidence of diabetes seems to be six times greater in cancer patients than in the general population. Despite this high incidence, implementation of standard Guidelines on monitoring BG levels in the PC/SC setting is lacking and the existing Guidelines are mainly based on expert experience rather than real data obtained from well design studies as evidenced by a recent review. Currently, the available tool used to evaluate BG in PC/SC patients is mainly represented by the punctual finger-samples procedure, which is usually performed only when there is a suspect of hyperglycemia/hypoglycemia or routinely in PC patients with known DM before meals administration. Punctual finger-samples procedure has many limitations: it is uncomfortable and painful for patients, it requires training to patients and family members by Health Care Providers (HCPs) and requires time to HPCs for preparing/conducting the procedures. As a consequence, BG monitoring in PC/SC patients (especially in home care settings) with known DM and newly diagnosed DM is very poorly and infrequently performed and represents a real unmet medical need. Recently, a very innovative device, Freestyle Libre 2 (FSL2) (Abbott), has obtained a CE mark for Continuous Glucose Monitoring (CGM) in diabetic patients. The system includes a self-applied sensor with a size of two-stacked quarters, that is easy to apply on the back of the upper arm; it employs a pre-calibrated sensor that measures the tissue glucose concentration repeatedly for two weeks and has a duration of accuracy measurements of 14 consecutive days; interstitial Glucose levels are easily check with a painless one-second scan by a smartphone App or a Reader with results represented by latest glucose concentration and trend direction. The scan with the App or the Reader should be applied at least every 8 hours in order to have the recording of the glucose level. FSL2 has real-time glucose alarms that notify if glucose level is going too low or too high (Free Style Libre 2 User's Manual). The rationale of the proposed study is based on the CGM system using FSL2, that is highly matching the need of Glucose level monitoring in PC/SC patients with known or newly diagnosed (i.e. iatrogenic) DM. FSL2 has no/very little discomfort for patients and it is not painful, it is easy to apply, it is not time-spending for family members and HCPs and it requires very brief training for patients and family members. The alarm system of FSL2 can aware patients, family members and HCPs at any moment when the glucose level is over a predefined cut off value, allowing to implement the appropriate interventions (i.e. insulin administration or insulin dose adjustment) in order to prevent and manage Symptomatic hyperglycemia crisis. The recent International Consensus on Recommendations on CGM data interpretation are showing that in particularly frail population, Glucose level are maintained for 50% of the time in a range between 70 mg/dL and 180 mg/dL and for 50% of the time in a range between 180 mg/dl and 250 mg/dl. According to that Recommendations, the alarm could be activated when glucose is over a cut off level of 180 mg/dL. The alarm activation allows patients themselves, family members, HCPs to provide patients with the most appropriate intervention (i.e. administration or adjustment of insulin dosage) in order to prevent glucose level reaching the peak of severe hyperglycemia (>250 mg/dl). Similarly, FSL2 allows to monitor Glucose level decrease and to prevent severe hypoglycemic crisis (BG <50 mg/dL). On this basis, we would like to evaluate CGM by using FSL2 as a tool for appropriately managing Glucose levels in PC/SC advanced oncological patients with known or newly diagnosed DM in order to prevent severe hypoglycemic/hyperglycemic crisis, in comparison to the current usual procedures (finger samples procedures). CGM by using FSL2 could have a very positive impact in improving glucose level management in the PC/SC setting, especially in the home care setting, contributing to an improvement of the QoL of patients/family members and the HCPs attitude to the importance of glucose level monitoring. The results of this study could lead to a new standard of care in the management of patients with advanced cancer with a known/newly diagnosed DM in PC/SC settings. The study is a multicenter, multinational, randomized, open label, parallel groups study, conducted in order to show superiority of CGM by using FSL2 in comparison to usual care procedures (finger samples) in reducing severe hyperglycemic peaks in PC/SC advanced oncological patients with known/newly diagnosed DM. An interim analysis is foreseen when the half of the expected events (hyperglycemic peaks) will be observed. In case the results of interim analysis show superiority of the CGM (FSL2) group in respect to the control group, patients of the control group will be switched to CGM by using FSL2 and will be followed until the completion of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palliative Care, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Diabetes, Cancer, Terminal Cancer, Terminal Illness, End Stage Cancer, Advanced Cancer
Keywords
Palliative care, Diabetes, Cancer, Advanced cancer, End Stage Cancer, Terminal Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous Glucose Monitoring
Arm Type
Experimental
Arm Description
The FreeStyle Libre 2 Flash Glucose Monitoring System (FSL2) is a CGM device with real time alarms capability indicated for the management of diabetes in persons aged 4 and older. The Sensor holds eight (8) hours of data at a time. In order to have a daily diary of the Glucose level the patients or family or HCP must read the sensor (with reader or app) at least every height (8) hours. Every day at least three (3) scans of the sensor should be performed using the reader or the Smartphone App, generally at wake up in the morning, in the afternoon and at the time to go to sleep. The alarm system will be activated, so that the Glucose level is over the cut off limit of 180 mmol/L or when it is lower than the cut-off limit of 80 mmol/L, the patient and/or the family members and/or the caregiver will check the Glucose level by scanning the reader/smartphone over the sensor.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
This arm will perform the usual standard routine for blood glucose monitoring in patients with insulin therapy, that is represented by at least three finger pricks/die according to the usual standards routine of each center. Different frequency of finger pricks glucose measurements could be performed on the basis of health care professional patient assessment of each patient's needs.
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitoring
Intervention Description
FSL2 is an integrated continuous glucose monitoring (CGM) system that provides continuous glucose measurements every minute to provide glucose levels, trends and alerts. It is composed by a sensor and a reader. The Sensor, to apply on the back of the arm, continuously measures glucose concentration in interstitial fluid and has an 8-hour memory capacity. The Sensor is factory calibrated, does not require finger stick calibration and can be worn for up to 14 days. The reader is a small handheld device that monitors glucose values in real-time to provide alerts and alarms which, when enabled, warn the user of Low Glucose, High Glucose or Signal Loss and prompt the user to scan the Sensor. The FSL 2 System is CE mark, it is commercially available and in the current study it is being used in accordance with approved labeling. No modifications of FSL2 System have been performed for the utilization in the current study.
Intervention Type
Device
Intervention Name(s)
Standard Care
Intervention Description
The control group is represented by the usual standard way for blood glucose (BG) monitoring. The control group will use a lancing device for finger samples for collection of blood drop to be put in the test strips to be read in the Glucose meter. Lancing devices, lancets and test strips used in the comparison groups are CE marked and are used according to the user's instructions. Monitoring and/or self-monitoring of blood glucose using glucose meters and test strips provides quantitative measurements of fingerstick blood glucose at a single point in time for patients and their healthcare providers to monitor the effectiveness of glycemic control and make more immediate treatment with the right dosage of insulin. The usual standard routine for blood glucose monitoring in patients with DM and with insulin therapy is represented by at least three finger pricks/die according to the usual standards routine of each center.
Primary Outcome Measure Information:
Title
Evaluate CGM by using FSL2 in preventing severe hyperglycemia peaks
Description
First severe hyperglycemic peak (>250 mg/dL) observed during evaluation
Time Frame
From recruitment until last followup (8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged > or = 18 years Diagnosed with advanced oncological disease Known/newly diagnosed DM according to ADA criteria Need of a Insulin therapy and need of Glycemia Monitoring with at least three finger pricks/die Karnofsky Index >= 30 Provision of signed and dated informed consent form Exclusion criteria: Diagnosis of all types of Dementia Presence of severe psychiatric diseases/symptoms Kidney failure requiring dialysis Patients with implanted pacemaker
Facility Information:
Facility Name
Palliative care Service - Sheba Medical Centre
City
Ramat Gan
Country
Israel
Facility Name
Antea Foundation
City
Roma
ZIP/Postal Code
00135
Country
Italy
Facility Name
Centro di Cure Palliative "Insieme nella Cura" - Policlinico Universitario - Campus Bio-Medico (Roma)
City
Roma
Country
Italy
Facility Name
Unità Operativa Complessa di Oncologia Medica - Policlinico Univeristario Campus Bio-medico di Roma
City
Rome
Country
Italy
Facility Name
Fondazione FARO
City
Torino
Country
Italy
Facility Name
Hospiz im Park
City
Arlesheim
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

GLYPALCARE STUDY - Multicenter, Randomized Study for Evaluating Continuous Glucose Monitoring (CGM) by Using FreeStyle Libre 2 (FSL2) for Preventing Hyperglycemia/Hypoglycemia Crisis in Advanced Oncological Patients.

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